The Suppression of Toll Like Receptors by Insulin

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

Inflamamtion is considered to be the cause of atherosclerosis and heart disease.

It had three arms (groups): obese subjects (experimental), Normal weight subjects (active comparator) and one (experimental).

Obese (BMI \>30Kg/m2) subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr.

Normal weight subjects infused with insulin, dextrose and saline in this specific sequence 1 week apart. Each infusion will continue for up to 24 hr.

The registry classes the interventions as drug.

More on the Plan

Their previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect, on circulating blood cells and in plasma in healthy subjects and in critically ill patients.

Toll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses and are major determinants of the inflammatory response against foreign pathogens.

Also the researchers will be comparing the baseline levels of TLRs and TLRs related proteins as well as their modulation by insulin between normal, obese and DM subjects.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age: 20 to 65 years of age inclusive. Sex: male or female. Normal BMI (20-25). Age: 20 to 65 years of age inclusive. Sex: male or female.

The full record lists 14 inclusion and 18 exclusion criteria; among the exclusions: congestive heart failure; heart rate \<50 beats /minute; sick sinus syndrome.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the insulin resistance, prediabetes & type 2 diabetes participants and staff both knew the treatment.

It started in 2008-09 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Suppression of Toll Like Receptor (TLR) 2 mRNA by Insulin (time frame: 24 hours).

It also tracked 3 secondary outcomes, for example Change in TLR4 mRNA in MNC, Change in CD14 Expression in MNC and Fasting TLR2 mRNA Expression Levels in the 3 Cohorts.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) in 42 people with insulin resistance, prediabetes & type 2 diabetes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.